CDRH Director Jeffrey Shuren defended an agreement with industry to double device user fees over five years, in speaking to lawmakers last week, and argued that not all fees paid by individual companies would increase by a substantial amount.
Shuren Defends Tentative User Fee Agreement On The Hill
Commonly paid user fees, such as the small business 510(k) submission fee, would not increase as dramatically as an overall doubling of total device user fees would suggest, argued the CDRH director, in defending a tentative FDA-industry agreement at a House hearing.
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